BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4093184 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17101
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE SYSTEM WAS REMOVED DUE TO AN INFECTION IN (B)(6) 2013. THE INFECTION RESOLVED AND A NEW SYSTEM WAS IMPLANTED ON (B)(6) 2014. THE PATIENT MEDICAL STATUS PRIOR TO THE EVENT, ADDITIONAL SIGNS AND SYMPTOMS, CAUSE OF THE INFECTION, DRUG INFORMATION, ADDITIONAL TREATMENT/INTERVENTIONS, AND TROUBLESHOOTING/DIAGNOSTICS WERE NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT'S LAST REFILL PRIOR TO THE EVENT OCCURRED ON (B)(6) 2013. THE PATIENT EXPERIENCED POCKET EROSION AND MENINGEAL SIGNS/SYMPTOMS. THE PATIENT DID HAVE MENINGITIS. THE DATE OF THE ONSET OR DIAGNOSIS OF THE INFECTION WAS (B)(6) 2013. THE PRIMARY LOCATION OF THE INFECTION WAS UNKNOWN. CULTURES WERE OBTAINED FROM THE DEVICE POCKET AND CEREBROSPINAL FLUID (CSF) AND REVEALED A GRAM-POSITIVE ORGANISM. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED AND A TOTAL DEVICE SYSTEM EXPLANT WAS DONE IN (B)(6) 2013. IN REGARDS TO PATIENT OUTCOME, THE INFECTION RESOLVED AND THE PATIENT EXPERIENCED DRUG WITHDRAWAL SYMPTOMS, SPECIFIED AS HYPERTHERMIA, BEHAVIORAL SYMPTOMS, TACHYCARDIA, AND REBOUND SPASTICITY. THE PATIENT'S PRE-EXISTING DEBILITATED STATUS WAS INDICATED TO BE A RISK FACTOR. IT WAS NOTED THAT THE PATIENT'S PUMP WAS PLACED IN THE PATIENT'S RIGHT UPPER QUADRANT AND THE CATHETER TIP WAS PLACED IN THE THORACIC. HOWEVER, THE SPECIFIC LOCATION WAS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572767 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention